Until now, autologous fresh blood components have been generally introduced inside specific vessels, of the micro test tube type, having relative closing caps, from which an operator then takes the desired quantity and introduces it inside a plurality of containers intended for use on the patient.
Because these operations require the transfer of the blood components from one container to another, and therefore their transit into the external environment, they must obviously be performed in a sterile environment. Furthermore, the preparation of such containers must be done by trained medical or nursing personnel inasmuch as the therapeutic effectiveness of the preparation is strongly affected by the quality and ways in which the aforementioned phases are performed.
It follows therefore that this known method of preparing containers with autologous fresh blood components besides being complicated to perform is also unsafe from a sanitary viewpoint and not therefore implementable on the basis of the applicable regulations on the subject. In fact, the correct performance of the operations described above is strictly correlated to the skills of the dedicated staff and to the environment where they are performed. These factors are highly restrictive inasmuch as they expose the preparation of the autologous blood component containers to various risks.
Another known method for the preparation of autologous blood component containers envisages filling a duct (dialysis infusate source) made of plastic material and closing such duct, e.g., by sealing in correspondence to a plurality of areas arranged in succession and spaced the one from the other, in such a way as to form a plurality of closed units.
These units are then opened, before being used, by cutting one of their respective extremities, e.g., using scissors, so as to make their contents available for use.
This second method for the preparation of units containing platelet-rich plasma also has several drawbacks.
More in particular, the units of known type are not easy and safe to use and do not allow compliance with the hygienic-health requirements of applicable regulations as well as of haemoderivative certification bodies.
In fact, the opening of such units by means of scissors or the like, results in residues of organic material contained in the relative unit remaining on the scissors cutting area, with the consequent risk of contaminating the contents of the other units subsequently cut with the same scissors.
This obviously involves the risk that the platelet contents of the units cut using already previously-used scissors will be polluted by the residues still on the scissors themselves, thereby negatively affecting their therapeutic properties and, above all, considerably increasing the risk of secondary infections in already immunodepressed patients and already debilitated organs.